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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Historical patient data from other published studies in the literature | ||
| Study participants | Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail who had at least 6 months of follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depuy Synthes Advanced Retrograde femoral nail | Device | The Advanced Retrograde Femoral Nailing System (RFNA) is designed to improve fixation and stabilization of distal femur and femoral shaft fractures by reducing toggle and loss of reduction. |
| Measure | Description | Time Frame |
|---|---|---|
| Union | Rate of fracture union | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Rate of infection | 6 months |
| Implant breakage | Rate of implant breakage | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail.
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| Name | Affiliation | Role |
|---|---|---|
| Clay Spitler, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16814787 | Background | Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30. | |
| 23518071 | Background | Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthop Traumatol Surg Res. 2013 May;99(3):353-60. doi: 10.1016/j.otsr.2012.10.014. Epub 2013 Mar 18. |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Implant removal | Rate of symptomatic implant removal | 6 months |
| Malunion | Rate of malunion | 6 months |
| 19411641 | Background | Ricci WM, Gallagher B, Haidukewych GJ. Intramedullary nailing of femoral shaft fractures: current concepts. J Am Acad Orthop Surg. 2009 May;17(5):296-305. doi: 10.5435/00124635-200905000-00004. |
| 7965294 | Background | Iannacone WM, Bennett FS, DeLong WG Jr, Born CT, Dalsey RM. Initial experience with the treatment of supracondylar femoral fractures using the supracondylar intramedullary nail: a preliminary report. J Orthop Trauma. 1994 Aug;8(4):322-7. doi: 10.1097/00005131-199408000-00008. |
| 11232660 | Background | Ricci WM, Bellabarba C, Lewis R, Evanoff B, Herscovici D, Dipasquale T, Sanders R. Angular malalignment after intramedullary nailing of femoral shaft fractures. J Orthop Trauma. 2001 Feb;15(2):90-5. doi: 10.1097/00005131-200102000-00003. |
| 17805018 | Background | Tucker MC, Schwappach JR, Leighton RK, Coupe K, Ricci WM. Results of femoral intramedullary nailing in patients who are obese versus those who are not obese: a prospective multicenter comparison study. J Orthop Trauma. 2007 Sep;21(8):523-9. doi: 10.1097/BOT.0b013e31813347ac. |
| 8814571 | Background | Gregory P, DiCicco J, Karpik K, DiPasquale T, Herscovici D, Sanders R. Ipsilateral fractures of the femur and tibia: treatment with retrograde femoral nailing and unreamed tibial nailing. J Orthop Trauma. 1996;10(5):309-16. doi: 10.1097/00005131-199607000-00004. |
| 10434075 | Background | Moed BR, Watson JT. Retrograde nailing of the femoral shaft. J Am Acad Orthop Surg. 1999 Jul-Aug;7(4):209-16. doi: 10.5435/00124635-199907000-00001. |
| 16810555 | Background | Oh CW, Oh JK, Park BC, Jeon IH, Kyung HS, Kim SY, Park IH, Sohn OJ, Min WK. Retrograde nailing with subsequent screw fixation for ipsilateral femoral shaft and neck fractures. Arch Orthop Trauma Surg. 2006 Sep;126(7):448-53. doi: 10.1007/s00402-006-0161-2. Epub 2006 Jun 21. |
| 26126587 | Background | Shah S, Desai P, Mounasamy V. Retrograde nailing of femoral fractures: a retrospective study. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1093-7. doi: 10.1007/s00590-015-1658-6. Epub 2015 Jul 1. |
| 15289684 | Background | Jaarsma RL, Pakvis DF, Verdonschot N, Biert J, van Kampen A. Rotational malalignment after intramedullary nailing of femoral fractures. J Orthop Trauma. 2004 Aug;18(7):403-9. doi: 10.1097/00005131-200408000-00002. |
| 16683109 | Background | El-Kawy S, Ansara S, Moftah A, Shalaby H, Varughese V. Retrograde femoral nailing in elderly patients with supracondylar fracture femur; is it the answer for a clinical problem? Int Orthop. 2007 Feb;31(1):83-6. doi: 10.1007/s00264-006-0137-4. Epub 2006 May 9. |
| 11265005 | Background | Ricci WM, Bellabarba C, Evanoff B, Herscovici D, DiPasquale T, Sanders R. Retrograde versus antegrade nailing of femoral shaft fractures. J Orthop Trauma. 2001 Mar-Apr;15(3):161-9. doi: 10.1097/00005131-200103000-00003. |
| 16499912 | Background | Singh SK, El-Gendy KA, Chikkamuniyappa C, Houshian S. The retrograde nail for distal femoral fractures in the elderly: high failure rate of the condyle screw and nut. Injury. 2006 Oct;37(10):1004-10. doi: 10.1016/j.injury.2006.01.005. Epub 2006 Feb 24. |